Finding a balance with hormone replacement therapy

Imagezoo via Getty Images

Imagezoo via Getty Images

Julie Deardorff, Tribune Newspapers

After a decade of rancorous debate over the risks and benefits of menopausal hormone therapy, experts from more than a dozen top medical organizations worldwide have finally come to something resembling a consensus. What did they decide, and why are women still baffled?

What is menopausal hormone therapy?

Also called hormone replacement therapy, it's a treatment for women in the throes of menopause, the inevitable period of life when estrogen naturally declines. Taking estrogen or a combination of estrogen and another hormone, progestin, the synthetic form of progesterone, can alleviate some of the symptoms of menopause, including hot flashes, night sweats, insomnia and vaginal dryness, said Atlanta endocrinologist Scott Isaacs. Women typically hit menopause around age 51.

Why is hormone therapy controversial?

Hormone therapy has been under intense scrutiny since 2002, when a large study called the Women's Health Initiative reported that taking additional hormones — specifically the combination of estrogen and progestin — increased the risk of blood clots, stroke, breast cancer, heart attacks and gall bladder disease for some women. For a woman with a uterus, estrogen treatment alone raises her chance of getting endometrial cancer. The researchers abruptly halted the study, concluding that risks outweighed benefits. Almost overnight, millions of women abandoned hormone therapy.

What have we learned over the last 10 years?

Hormone therapy still has an important role in treating women who have symptoms, but it shouldn't be used to prevent disease. It's best to take the lowest possible dose for the shortest amount of time. For symptom relief, "if you're healthy and in your 50s, and it has been less than 10 years since menopause, it's pretty much a green light," said Dr. Cynthia Stuenkel a clinical professor of medicine at the University of California at San Diego. Hormone therapy is also beneficial for bone health and may decrease mortality and cardiovascular disease. But it's not right for everyone; the risk level depends on a woman's age, health history and the number of years since her menopause began, according to The Endocrine Society.

What's still up for debate?

Whether hormone therapy has a preventive role, Stuenkel said. There's some evidence that estrogen therapy can effectively reduce heart disease, but "it's not universally agreed on," she said. Estrogen has a positive effect on bones and can help with treating osteoporosis, but it's not a first-line treatment, Isaacs added. Swiss researchers recently showed that boosting estrogen might enhance muscle strength in post-menopausal women. Still, last year the U.S. Preventive Services Task Force recommended against using hormonal therapy to prevent chronic conditions. Until more is known, "use hormones if you have symptoms," Stuenkel said. If you don't, make some lifestyle changes to help prevent heart disease and other aging-related issues.

"Move more, try the Mediterranean diet, stop smoking. Eat, drink and be merry with a friend," she suggested.

William Young, president of The Endocrine Society, stressed that for healthy women under 60 who are in early menopause, hormone therapy can safely treat hot flashes, mood swings and vaginal dryness.

"Too many women don't know this or are so confused about hormone therapy that they are not receiving any treatment at all," Young said.

What about breast cancer?

It's complicated. The increased risk, which is small, is primarily due to adding progesterone to estrogen therapy. Basically, after age 50 a woman has a 3 in 1,000 chance of developing breast cancer. If she uses combined hormone therapy for a year, the same therapy used in the Women's Health Initiative study, her risk will be 4 in 1,000, Stuenkel said.

"That can be expressed as a 33 percent increased risk, which to most of us sounds much more ominous than an increase of 1 per 1,000," she said.

For women who haven't had a hysterectomy, progesterone can help prevent uterine cancer, Isaacs said. "But some of the heart disease issues have been tied to progesterone," he said. A recent study in the Journal of the National Cancer Institute provided more evidence showing estrogen plus progestin in post-menopausal women is linked to an increased risk for breast cancer.

"Risk is also age-related," Isaacs said. The safest candidate is a young woman who may have had a hysterectomy, who uses low doses over a short time and uses a patch. A patch is safer than a pill because a pill can lead to blood clots, he said.

Are there natural options for relief of hot flashes?

Breathing, relaxation techniques and clinical hypnosis show the most promise. Native Americans traditionally used the herb black cohosh to treat menstrual irregularity; research suggests it could have a role in menopause. But a systematic review of 16 studies found there's not enough evidence to support the use of black cohosh. Phytoestrogens, which are found in soy, have run into the same problem. Though popular, the studies are of poor quality, and, so far, soy hasn't been shown to be effective. Researchers at the Botanical Center at the University of Illinois at Chicago are investigating the safety and efficacy of several plants, including black cohosh, red clover, chaste berry, valerian, hops and dong quoi.

How do I know if I need hormonal therapy?

Try an interactive tool called the "Menopause Map" at hormone.org/menopausemap, which Stuenkel helped develop. The map guides women through the different available options and weighs both hormonal and nonhormonal treatments. In addition to feeling "blah" or "off," some of the chief symptoms of menopause include fatigue, insomnia, moodiness, hot flashes, temperature sensitivity and a loss of sex drive or painful intercourse. If you're considering hormone therapy, consider talking to your gynecologist or an endocrinologist.

What are bio-identical hormones?

Depends on who you ask. The term bio-identical implies that the hormones are similar to the ones produced by the body. But all bio-identical hormones are synthetically made. The term bio-identical is used for marketing and is not recognized by the Food and Drug Administration.

"Oral estradiol, transdermal patches, estradiol sprays, gels and micronized progesterone are all chemically very close to identical to native hormones," Stuenkel said. "Maybe a better term would be 'biochemically identical,'" she said.

Compounded hormones are most commonly referred to as "bio-identical," which contributes to consumer confusion. These hormones are prepared by compounding pharmacies, require a prescription and carry the same risks as conventional hormones.

Bio-identical hormones may contain two or three different types of estrogen rather than one. They often contain estriol, a form of estrogen that, while regarded as safe, hasn't been approved by the FDA. "Although unapproved, estriol products are legal if prescribed by a physician and compounded by a qualified pharmacist," Isaacs wrote in his book "Hormonal Balance: How to Lose Weight by Understanding Your Hormones and Metabolism."

Often marketed as a health tonic that's a "natural, safer alternative to dangerous prescription drugs," bio-identical hormones became popular after the Women's Health Initiative scared many menopausal women away from conventional treatment. But "there's no proof that they are safer or more effective than traditional hormones," Isaacs said. Compounding pharmacies generally are not required to register with the FDA or to report the products that they produce.

The FDA has taken action against several pharmacies that make unsupported claims related to bio-identical hormones. The use of custom-compounded bio-identical therapy is not recommended by mainstream medical organizations, including the American Medical Association, the American Society for Reproductive Medicine, The Endocrine Society and the North American Menopause Society.